Quality control of prednisolone sodium phosphate

Abstract

Prednisolone sodium phosphate is believed to undergo hydrolysis of the phosphate ester group as its primary degradation pathway. Most published assay methods do not determine the phosphate ester directly, and therefore a high-performance liquid chromatographic method has been developed for prednisolone sodium phosphate in the presence of its breakdown products, which has been validated in the presence of excipients used in ophthalmic solutions. Stability data are presented that are comparable to those obtained for related steroid phosphate esters. The stability data indicate that a simpler ultraviolet spectrophotometric assay method can be used for routine stability testing.